BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGNA HORIZON LX SHORT BORE SR77 1.5T

    MDR report key: 457028 · Received April 29, 2003

    Report

    Report Number
    MW1028289
    Event Type
    Other
    Date Received
    April 29, 2003
    Date of Event
    April 7, 2003
    Report Date
    April 22, 2003
    Manufacturer
    GE MEDICAL SYSTEMS, GENERAL ELECTRIC COMPANY
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT FELT INTERMITTENT PAIN IN HAND AND LEG WHILE UNDERGOING THORACIC SPINE MRI. TWO-THREE DAYS FOLLOWING MRI, PT NOTED OPEN SORES SIZE OF PENCIL ERASER, ON HAND AND LEG. ASSESSMENT OF MRI TECHNQUE AND PT POSITIONING CONFIRMED THAT PT NOT IN CONTACT WITH MAGNET NOR ANY METAL OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA HORIZON LX SHORT BORE SR77 1.5T MRI UNIT LNH GE MEDICAL SYSTEMS, GENERAL ELECTRIC COMPANY LCC *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other